Why eCTD

1. Why eCTD?
Electronic Common Technical
Document – Importance and
Advantages

2. Why eCTD? – Key Reasons
• Regulatory Requirement: Mandatory in US,
EU, Canada, Japan, Australia
• • Standardized Format: Harmonized Modules
1–5 across ICH regions
• • Efficient Life Cycle Management: Track
updates, replacements, and deletions
• • Faster Review Process: XML backbone,
hyperlinks, and bookmarks ease navigation
• • Environmentally Friendly: No paper, reduced
printing and shipping costs

3. Why eCTD? – More Benefits
• Improves Submission Quality: Validated
structure reduces rejection risk
• • Easy Collaboration and Updates: Ideal for
multi-country submissions
• • Supports Reuse of Data: Common
documents can be reused across regions
• • Faster Regulatory Communication: Easy to
respond to queries and upload updates
• • In Summary: eCTD offers speed, consistency,
compliance, and global harmonization